FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
CRYOcheck FVIII Inhibitor Kit
K Number: K183440
·
Decision Mar 12, 2019
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- CRYOcheck FVIII Inhibitor Kit
- K Number
- K183440
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Biologic, Inc.
- Date Received
- December 12, 2018
- Decision Date
- March 12, 2019
- Product Code
- GGP
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GGP), ordered by most recent decision date.
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FDA 510(k)
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Other Clearances by Precision Biologic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIII | Aug 25, 2025 | Substantially Equivalent |
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Sep 13, 2023 | Substantially Equivalent |
| K214002 | CRYOcheck Chromogenic Factor IX | Dec 23, 2022 | Substantially Equivalent |
| K060284 | CRYOCHECK CLOT APCR | May 10, 2006 | Substantially Equivalent |
| K043571 | CRYOCHECK CLOT S | Mar 18, 2005 | Substantially Equivalent |
| K040987 | CRYOCHECK CLOT C | Jun 18, 2004 | Substantially Equivalent |